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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
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The purpose of this study is to evaluate the safety and efficiency of allogeneic cluster of differentiation 19 (CD19)-directed chimeric antigen receptor modified T cells (CART-19) infusions in patients with relapsed / refractory B-cell acute lymphoblastic leukemia (B-ALL)
The relapsed and/or refractory B-ALL patients will receive infusions of allogeneic CART-19 within 1 week after chemotherapy. The re-induction chemotherapy regimen was primarily vindesine, mitoxantrone, cyclophosphamide, pegaspargase and dexamethasone, and no graft-versus-host disease (GVHD) prevention was conducted pre- and post- therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allogeneic CART-19 | Experimental | infusions of allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| allogeneic CART-19 | Biological | allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate of allogeneic CART-19 | An objective response is defined as: (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) or (3) a negative minimal residual disease assessed by flow cytometry or qPCR | up to 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huisheng Ai, MD | Contact | 861066947135 | huishengai@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huisheng Ai, MD | Affiliated Hospital of Academy of Military Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Academy of Military Medical Sciences , | Recruiting | Beijing | Beijing 100071 | 100071 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27887660 | Derived | Cai B, Guo M, Wang Y, Zhang Y, Yang J, Guo Y, Dai H, Yu C, Sun Q, Qiao J, Hu K, Zuo H, Dong Z, Zhang Z, Feng M, Li B, Sun Y, Liu T, Liu Z, Wang Y, Huang Y, Yao B, Han W, Ai H. Co-infusion of haplo-identical CD19-chimeric antigen receptor T cells and stem cells achieved full donor engraftment in refractory acute lymphoblastic leukemia. J Hematol Oncol. 2016 Nov 25;9(1):131. doi: 10.1186/s13045-016-0357-z. |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Disease-free survival | up to 24 weeks |
| Overall survival | up to 24 weeks |
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |